Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its third quarter 2011 results.
Third Quarter 2011 Highlights:
- Third quarter revenues increased 11% to $1.3 billion, compared to the third quarter of 2010. TYSABRI® (natalizumab) revenues increased 26% year-over-year to $277 million while AVONEX® (interferon beta-1a) revenues increased 6% year-over-year to $682 million. RITUXAN® (rituximab) revenues from our unconsolidated joint business arrangement were $266 million for the quarter, an increase of 3% versus prior year.
- Global in-market sales of TYSABRI in the third quarter of 2011 were $393 million, an increase of 28% over the third quarter of 2010. The total was comprised of $197 million in U.S. sales and $195 million in sales outside the U.S.
- On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), third quarter 2011 GAAP diluted EPS were $1.43, an increase of 36% over the third quarter of 2010. GAAP net income attributable to Biogen Idec for the quarter was $352 million, an increase of 38% from the third quarter of 2010.
- Non-GAAP diluted EPS for the third quarter of 2011 were $1.61, an increase of 19% over the third quarter of 2010. Non-GAAP net income attributable to Biogen Idec for the third quarter of 2011 was $395 million, an increase of approximately 20% from the third quarter of 2010. A reconciliation of our GAAP to non-GAAP results is included on Table 3 within this press release.
As of September 30, 2011, Biogen Idec had cash, cash equivalents and marketable securities of approximately $2.9 billion.
"This has been a quarter of tremendous accomplishments for Biogen Idec," said George A. Scangos, Ph.D., the company's chief executive officer. "We continued to deliver strong product and financial performance driven by the growth of TYSABRI. The recent positive data readout from the CONFIRM trial of BG-12 is a truly meaningful development for our company and for multiple sclerosis patients, and we are thrilled by it. We now have strong results for BG-12 in two large and robust clinical trials and we anticipate filing for approval in the first half of next year with the intent of bringing this potentially major new therapy to MS patients as soon as possible. We continue to improve the quality of our pipeline by concentrating on cutting-edge science with the greatest potential to help patients and drive growth, and we are focused on excellence in execution as we prepare for the potential of multiple product launches in coming years."
TYSABRI Patient Growth
Based upon data available to us through the TOUCH® prescribing program and other third-party sources, as of the end of September 2011, we estimate that approximately 63,500 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 92,200 patients have ever been treated with TYSABRI in the post-marketing setting.
Other Products and Royalties
Revenues from other products in the third quarter of 2011 were $17 million, compared to $12 million in the third quarter of 2010.
Table 4 provides individual product revenues.
Royalties were $52 million in the third quarter of 2011, an increase of 43% compared to the third quarter of 2010.
Corporate partner revenues in the third quarter of 2011 were $16 million, compared to $5 million in the third quarter of 2010.
Revised Financial Guidance
Biogen Idec also revised its full year 2011 financial guidance. This guidance consists of the following components:
- Revenue growth is expected to be in the mid-single digits versus 2010.
- Cost of Sales is expected to be approximately 9% to 10% of total revenue.
- R&D is expected to be at the high end of 22% to 24% of total revenue.
- SG&A is expected to be at the high end of 20% to 21% of total revenue.
- Tax rate is expected to be approximately 26% to 28% of pretax income.
- GAAP diluted EPS is expected to be above $4.91.
- Non-GAAP diluted EPS is expected to be above $5.70.
- Capital expenditures are expected to be in the range of $200 to $220 million.
Biogen Idec may incur charges, realize gains or experience other events in 2011 that could cause actual results to vary from this guidance.
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